Disparities of oral health care are a significantly under-addressed area of health disparities. A substantial population, primarily those who are socioeconomically disadvantaged and of ethnic groups including Hispanics, African Americans and Native Americans, have alarmingly poor access to oral health care. Dental pulp is vascularized connective tissue in the central core of a tooth, and maintains homeostasis of the tooth as a biologically viable organ. When caries or trauma involves dental pulp, endodontic therapies are indicated. In irreversible pulpitis, the dentist or endodontist extirpates dental pulp, and obturates the instrumented root canal with bioinert materials. A total of approximately 16 million endodontic procedures are performed each year in the United States alone. However, individuals of socioeconomically disadvantaged populations have little access to root canal therapy, and frequently have their infected teeth extracted. Whereas root canal therapy is one of the successful dental treatments, complications have been repeatedly documented in the literature. Secondary infections due to coronal leakage or undetected accessory canals are not uncommon, and require re-treatment. A substantial amount of tooth structure is removed during root canal treatment, leading to increased incidences of tooth fracture. Root canal treated teeth are devoid of innervation and pulpal sensation, and thus are deprived of the ability to detect secondary infections. Our preliminary data demonstrate, for the first time, that endodontically treated human teeth are recellularized and revascularized in vivo. Accordingly, the overall goal of this SBIR/Phase-I proposal is to develop biologically based approaches for dental pulp regeneration at a cost that is substantially less than the current root canal therapy and readily accessible by underserved populations who currently have little access to conventional root canal therapy. PUBLIC HEALTH RELEVANCE: This SBIR/Phase I project will address a substantial disparity in oral health care by developing novel therapies for dental pulp regeneration. A total of approximately 16 million endodontic procedures are performed each year in the United States alone. However, current root canal therapy is an expensive dental treatment with alarmingly poor access by socioeconomically disadvantaged populations, and yet leads to de-vitalized pulp tissue. We have generated preliminary data to demonstrate that dental pulp regeneration can be realized in human teeth at a fraction of the cost of current root canal therapy. We propose to take advantage of the SBIR mechanism to develop biologically based, regenerative root canal therapy that is affordable and accessible by underserved populations.